Clinical and Medico-economic Validation of the HEPHAI Solution.

NCT06099145 | Unknown

• 1 other identifier: KM00385
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 5

Brief Summary

In a context where the use of inhalation devices for respiratory medications is associated with a high frequency of critical errors, our primary hypothesis is that the use of the HEPHAÏ solution reduces this frequency compared to standard care. The objective of this clinical study is to evaluate the performance of the HEPHAÏ solution as a tool for improving the administration of inhaled treatments in patients undergoing pulmonary care for asthma and/or COPD, who are receiving treatment with Innovair® or Trimbow®. These two inhalers were chosen for reasons of feasibility and compatibility with the version of the HEPHAÏ software provided as part of the clinical investigation

Conditions

Asthma COPD

Outcome Measures

Primary Outcomes (1)

• Proportion of Critical Errors at week 12

  Assessment of the proportion of critical errors during inhaler use, from baseline to 3 months after initiation of the intervention. A critical error is defined as an error during use of the device that would compromise access of the inhaled medication to the respiratory tract, The methodology used to assess critical errors consists in comparing the results of the investigating physician's observation of use with a reference checklist developed on the basis of official recommendations for use.

  Baseline and week 12

Secondary Outcomes (3)

• Proportion of Critical Errors at week 24

  Baseline to week 24

• Quality of Life Assessment (Saint-Georges' Hospital Questionnaire)

  Baseline to week 24

• Quality of Life Assessment (EQ5D5L Questionnaire)

  Baseline to week 24

Study Arms (2)

Standard care

NO INTERVENTION

Patient who received inhaled treatment with Innovair® or Trimbow® as a part standard care for 6 months

Hephai

EXPERIMENTAL

Patient using the Hephaï medical device as a tool who received inhaled treatment with Innovair® or Trimbow® as a part standard care for 6 months

Device: Hephaï

Interventions

Hephaï DEVICE

Used of the HEPHAI medical device as a tool to improve the delivery of inhaled treatments for asthma and COPD

Hephai

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient at least 18 years of age
• Patient followed in pulmonology for Asthma and/or COPD with implementation and/or follow-up of treatment with Innovair® or Trimbow®,
• Patient affiliated to a Social Security scheme,
• Patient with a hardware support allowing the operation of HEPHAÏ: smartphone, tablet, desktop or laptop computer with graphical interface, video, sound and a high-speed connection at the place of use.

You may not qualify if:

• Patient previously enrolled in another interventional clinical study,
• Adult patients who are subject to a legal protection measure (guardianship, judicial safeguard, psychiatric care or deprived of liberty by judicial or administrative decision),
• Patient with at least one sensory, visual or tactile impairment, preventing the correct use of a smartphone, tablet and/or computer or preventing the correct performance of the exercise safely,
• Patient with a cognitive impairment, severely limiting their ability to concentrate and thus preventing the correct use of a smartphone, tablet and/or computer,
• Patient cared for by a specialized team of education, therapeutic for his asthma or COPD follow-up (e.g. asthma school, asthma referent IDE),
• Patient who does not understand French,
• Patient with an inhalation chamber prescription associated with their inhalation device prescription.

Sponsors & Collaborators

• Hephai: lead

Study Sites (5)

CHU de Dijon

Dijon, 21079, France

NOT YET RECRUITING

Hôpital Arnaud de Villeneuve

Montpellier, 34090, France

NOT YET RECRUITING

Pitié-Salpêtrière Hospital

Paris, 75011, France

RECRUITING

Hôpital COCHIN

Paris, 75014, France

NOT YET RECRUITING

Hôpital BICHAT

Paris, 75018, France

RECRUITING

Study Officials

• Capucine Capucine.morelot@aphp.fr, Prof.

  Department of Pneumonology, Pitié-Salpêtrière Hospital,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serge Kinkingnehun

CONTACT

+33 6 61 85 06 77; serge@hephai.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an interventional, multicenter, randomized, controlled clinical study.

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: September 19, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

FR (5)